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FDA Orange Book · active-ingredient family

Umeclidinium bromide

Umeclidinium bromide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:INCRUSE ELLIPTA · NDA 205382

1

Brand (NDA)

0

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · powder

ProductApplicantApplicationTEApproved
INCRUSE ELLIPTARLDGLAXO GRP ENGLANDNDA 205382—Apr 30, 2014

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7488827Dec 18, 2027in 1 yr 6 mo
SubstanceProduct

Umeclidinium bromide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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